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Dimethyl fumarate has been associated with progressive multifocal leukoencephalopathy (PML) in patients with multiple sclerosis; all had prolonged lymphopenia. For full details of this warning and recommended patient monitoring, both before and during treatment, see Drug Safety Update April 2016.

Prescribing notes

Dimethyl fumarate is recommended as a possible treatment for adults with active relapsing-remitting mulitple sclerosis that isn't highly active or rapidly evolving severe relapsing-remitting multiple sclerosis. It is for specialist use and will be prescribed according to NICE guidance.

Fingolimod is known to cause transient bradycardias and heart block after the first dose and when restarting treatment after a treatment break. Fingolimod is contra-indicated in patient groups at high risk of cardiovascular adverse events, such as those with significant QT prolongation or history of bradycardia, ischaemic heart disease, cardiac failure, cerebrovascular disease, uncontrolled hypertension and those receiving antiarrhythmic or heart-rate lowering drugs. All patients should be monitored before, during and immediately after the first 6 hours or treatment. Enhanced monitoring is required in some instances. For full details, see Drug Safety Update May 2012andDrug Safety Update January 2013.

A suspected rebound syndrome (clinical and radiological signs of severe exacerbation beyond what was expected for that patient prior to discontinuation or treatment change) has been described in patients with multiple sclerosis after treatment with fingolimod (Gilenya®) was stopped, some of whom were switched to other treatments.Healthcare professionals should report any suspected adverse effects relating to fingolimod (Gilenya®) or other treatments for multiple sclerosis, including suspected adverse effects occurring after discontinuation, via the Yellow Card Scheme, see Drug safety Update, April 2017

Prescribing notes

Fingolimod is an immunomodulating drug licensed for use in patients with highly active relapsing-remitting mulitple sclerosis despite treatment with interferon beta, or in those with rapidly evolving severe relapsing-remitting mulitple sclerosis. It is for specialist use only and is prescribed according to NICE guidance.

For women of child-bearing potential, pregnancy must be excluded before starting treatment with linalidomide or thalidomide (perform pregnancy test on initiation or within 3 days prior to initiation). Women must practise effective contraception at least 1 month before, during and for at least 1 month after treatment, including during dose interruptions (oral combined hormonal contraceptives and copper-releasing intrauterine devices not recommended). Men should use condoms during treatment, during dose interruption and for at least 1 week after stopping if their partner is pregnant or is of child-bearing potential and not using effective contraception. Patients, prescribers and pharmacists must comply with pregnancy prevention measures as specified in the manufacturer's Pregnancy Prevention Programme.

Thalidomide - use a lower starting dose 100mg/day in patients older than 75 with untreated multiple myeloma. This is to reduce the incidence of adverse effects.

Progressive multifocal leukoencephalopathy (PML) is a rare, progressive and demyelinating disease of the CNS that may be fatal. Use of natalizumab has been associated with an increased risk of PML. For advice on the management of both new patients and those receiving ongoing treatment, including detailed risk estimates, see Drug Safety Update, April 2016.

Prescribing notes

Natalizumab has been approved by NICE as a treatment option only in rapidly evolving severe relapsing-remitting multiple sclerosis. This is a specialist drug and is prescribed according to NICE guidance.

Teriflunomide is a metabolite of leflunomide which has immunomodulating and anti-inflammatory properties. It is licensed for the treatment of adults with relapsing-remitting multiple sclerosis. Teriflunomide should be initiated and supervised by a physician experienced in the managment of multiple sclerosis.

Teriflunomide has been approved by NICE for treating adults with active relapsing-remitting multiple sclerosis, (normally defined as 2 clinically significant relapses in the previous 2 years), only if they do not have highly active or rapidly evolving severe relapsing-remitting multiple sclerosis. It is prescribed as per NICE guidance.

On this website you will now see four icons for these resources rather than two. Please use BNF Legacy or BNF for Children Legacy as these will take you to the original format of the online publications which do not have any errors or omissions.